NCT06108206

Adaptive Radiotherapy and MRIs Based on Patients With Newly Diagnosed High-Grade Glioma

Adaptive Radiotherapy Based on Multi-Parametric Diffusion- and Perfusion-weighted Magnetic Resonance Imaging in Patients With Newly Diagnosed High-Grade Glioma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if performing additional Magnetic Resonance Image (MRI) scans of the subjects' brain during each week of the radiation treatment of their high-grade glioma will help improve the radiation treatment.

Detailed description

Diffusion weighted imaging (DWI) and Perfusion-weighted imaging (PWI) are validated MRI techniques that aid in diagnosis, prognosis, and assessment of treatment efficacy and, while they are utilized in select clinical settings, they have yet to make their way into routine clinical practice at most centers. DWI is a non-invasive MRI modality that has demonstrated an ability to predict for a response to radiation therapy in the primary treatment of patients with glioblastoma (GBM). PWI is one collection of measures that includes dynamic susceptibility contrast (DSC) enhancement and dynamic contrast-enhanced (DCE) imaging. The latter methods of MRI-adapted radiotherapy allow the opportunity to direct high-dose radiation to areas most likely to harbor resistant tumor while avoiding regions having a low likelihood of future recurrence. Multiple MRI sequences have been developed and validated that may identify high-risk areas in patients with High-grade glioma (HGG) and the ability to acquire multiple sequential time points creates an opportunity for dynamic radiotherapy that has not previously been explored. The current standard of care in radiotherapy does not incorporate any additional neuroimaging data. This study hypothesizes that pre- and mid-treatment advanced imaging with (DWI) and (PWI) in patients with HGG can be used to generate an adaptive radiotherapy boost volume that correlates with areas of future recurrence and that this volume has a higher spatial correlation relative to the current standard of care.

Conditions

• Glioblastoma
• Anaplastic Astrocytoma
• Astrocytoma
• Anaplastic Oligodendroglioma

Interventions

Type	Name	Description
OTHER	Adaptive Radiotherapy	Each patient will undergo a brain MRI at the following time points: 1. Baseline- within 2 weeks prior to the start of chemo-RT, 2. Week #1- on Fractions # 4 or 5 3. Week #2- between Fractions # 6-10 (at least 5 days after the Week 1 MRI) 4. Week #3- between Fractions # 11-15 (at least 5 days after the Week 2 MRI) 5. Week #4- between Fractions # 16-20 gadolinium contrast (at least 5 days after the Week 3 MRI) 6. Week #5- on Fractions # 24 or 25 (after the start of the Conedown) 7. Week #6- +/- 3 days of Fraction #30 (end of RT) Patients receiving hypofractionated radiotherapy will undergo a brain MRI at the following time points: 1. Baseline- within 2 weeks prior to the start of your standard of care chemotherapy radiation treatment (chemo-RT), 2. Week #1 - on Fractions #4 or 5 3. Week #2 - between Fractions #6-10 (at least 5 days after the Week 1 MRI) 4. Week #3 - between Fractions #11-15 (at least 5 days after the Week 2 MRI)

Timeline

• Start date: 2024-01-30
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-10-30
• Last updated: 2025-07-03

Locations

1 site across 1 country: United States